{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-08-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "176932",
      "product_res_number": "Z-0596-2020",
      "event_date_initiated": "2017-08-15",
      "event_date_created": "2019-12-03",
      "recall_status": "Terminated",
      "event_date_terminated": "2020-05-05",
      "res_event_number": "83992",
      "product_code": "BTY",
      "k_numbers": [
        "K161534"
      ],
      "product_description": "EasyOne Pro Respiratory Analysis System Pulmonary Function Testing Device, Model 3000-1",
      "code_info": "Serial Numbers: 550066 550067 550068 550069 550071 550072",
      "firm_fei_number": "3002918917",
      "recalling_firm": "NDDd Medical Technologies, Inc.",
      "address_1": "2 Dundee Park Dr",
      "city": "Andover",
      "state": "MA",
      "postal_code": "01810-3735",
      "additional_info_contact": "Robert Weisman\n978-470-0923 Ext. 123",
      "reason_for_recall": "The CO/CO2 sensor cable harness may have lower electromagnetic shielding, which might have resulted in a non-compliance with the IEC 60601-1-2 standard.  As a consequence of a lower electromagnetic shielding provided by the cable harness, the CO/CO2 sensor could have been influenced by high frequencies emitted by very close devices.",
      "root_cause_description": "Component change control",
      "action": "Customers were contacted via email or telephone between 8/1/17 and 4/13/19.\n\nThe emails including the following information:\n\nWe wanted to inform you that we are planning a preventive repair for some of our recently delivered EasyOne\nPro/LAB V05 devices. The repair is related to an internal shielding component against electromagnetic disturbances.\nIn some rare cases this could potentially lead to DLCO or MBW that cannot be performed. Although the probability of\noccurrence is very low, we want to absolutely ensure the quality of our devices and therefore we would like to make\narrangements to update the shielding of this affected device. It is important to note, that all costs regarding the\nnecessary repair will be covered by ndd, including all potential expenses.\nI would like to discuss handling of the repair and covering of the cost at the time of the repair.\nOf course, we already ensured that all newly delivered devices are not affected by the shielding issue. You can\ntherefore order devices normally, there is no special action required.\nWe are very sorry for the inconvenience this might be causing you as well as our shared customers and are\ncommitted to help as much as possible to ensure a smooth exchange of the affected component.\nCan you please contact me so we can make arrangements?",
      "product_quantity": "37 total devices",
      "distribution_pattern": "The products were distributed to the following US states:  KY, MO, NY, OH, PA",
      "openfda": {
        "k_number": [
          "K863087",
          "K892705",
          "K062011",
          "K780584",
          "K120635",
          "K881122",
          "K993641",
          "K161534",
          "K911358",
          "K242809",
          "K864836",
          "K790579",
          "K932278",
          "K020745",
          "K181912",
          "K942211",
          "K980094",
          "K812792",
          "K190800",
          "K961252",
          "K812850",
          "K821712",
          "K080734",
          "K122699",
          "K223629",
          "K202754",
          "K173937",
          "K231561",
          "K861486",
          "K000648",
          "K031194",
          "K113813",
          "K823683",
          "K932744",
          "K855068",
          "K111053",
          "K040549",
          "K854745",
          "K082539",
          "K150888",
          "K221030",
          "K921309",
          "K853433",
          "K855069",
          "K823771",
          "K894667",
          "K080510",
          "K864087",
          "K803053",
          "K933511",
          "K071753",
          "K090722",
          "K091428",
          "K981366",
          "K222982",
          "K933839",
          "K883008",
          "K861487",
          "K810712",
          "K930085",
          "K812849",
          "K942230",
          "K850045"
        ],
        "registration_number": [
          "1000154583",
          "9615102",
          "2433214",
          "3037873864",
          "3008505660",
          "2134715",
          "3030308442",
          "8030673",
          "3033959233",
          "3002808458",
          "9680276",
          "3008072932",
          "8021084",
          "2183022",
          "9614485",
          "3010594620",
          "3016218294",
          "1314417"
        ],
        "fei_number": [
          "1000154583",
          "2433214",
          "3004213967",
          "3037873864",
          "3008505660",
          "3002673652",
          "3030308442",
          "3033959233",
          "3010320336",
          "3002808458",
          "1000271197",
          "3008072932",
          "2995",
          "3003007937",
          "2183022",
          "3010594620",
          "3016218294",
          "1314417"
        ],
        "device_name": "Calculator, Predicted Values, Pulmonary Function",
        "medical_specialty_description": "Anesthesiology",
        "regulation_number": "868.1890",
        "device_class": "2"
      }
    }
  ]
}